Without limiting the scope of the invention, its background is described in connection with nutritional supplements.
The multivitamin is the iconic and top selling nutritional supplement, with first versions showing up on the market in the 1940s. National Institutes of Health State-of-the-Science Conference Statement: Multivitamin/Mineral Supplements and Chronic Disease Prevention. Am. J. Clin. Nutr. 2007, 85, 257S-264S. Worldwide sales of multivitamins were estimated at 30 billion in 2015 and accounted for 60% of sales in the global nutritional supplement market. Although no health claims are specifically associated with multivitamins, most people (and industry marketing/education) imply multivitamin intake with decreased risk of both cancer and cardiovascular disease and improved cognition/performance.
Despite the preeminent stature of the multivitamin in the nutritional supplement market, the efficacy of the common multivitamin has been under recent attack. Several high profile studies have come out in recent years questioning the efficacy of the classic multivitamin. One of these was the study by Neuhouser et. al., who tracked multivitamin use in women with the risk of both cancer and cardiovascular disease. Neuhouser, et. al., Multivitamin Use and Risk of Cancer and Cardiovascular Disease in the Women's Health Initiative Cohorts. Arch. Intern. Med. 2009, 169 (3), 294-304. This study included 161,808 participants with continuous follow up for 8 years. The major takeaway, as summarized by the authors in their conclusion was as follows: “After a median follow-up of 8.0 and 7.9 years in the clinical trial and observational study cohorts, respectively, the Women's Health Initiative study provided convincing evidence that multivitamin use has little or no influence on the risk of common cancers, cardio vascular disease (“CVD”), or total mortality in postmenopausal women”.
Another study suggesting bad news for the classic multivitamin was published in 2013 by Fortmann, et. al. Fortmann, et. al. Vitamin and Mineral Supplements in the Primary Prevention of Cardiovascular Disease and Cancer: An Updated Systematic Evidence Review for the U.S. Preventive Services Task Force. Ann. Intern. Med. 2013, 159, 824-834. This study also included a large sample size (27,658) of participants and used sound methodology. The concluding paragraph of the article stated: “Limited evidence supports any benefit from vitamin and mineral supplementation for the prevention of cancer or CVD. Two trials found a small, borderline-significant benefit from multivitamin supplements on cancer in men only and no effect on CVD.”
The above cited papers and others prompted a widely shared editorial authored by medical doctors at the prestigious Johns Hopkins School of Medicine. Guallar, et. al. Enough is Enough: Stop Wasting Money on Vitamin and Mineral Supplements. Ann. Intern. Med. 2013, 159, 850-851. The authors summarized their key point of the editorial in the last paragraph of the article as follows: “Although available evidence does not rule out small benefits or harms or large benefits or harms in a small subgroup of the population, we believe that the case is closed—supplementing the diet of well-nourished adults with (most) mineral or vitamin supplements has no clear benefit and might even be harmful. These vitamins should not be used for chronic disease prevention. Enough is enough.” Thus, a need remains for nutritional supplements designed specifically to overcome the problems in the prior art.